PRACS spokeswoman Katherine Cloninger told Outsourcing-pharma.com that: “The sale was based on the new company’s decision to focus on core operations and key assets.
She added that: “There was overlapping capacity between the Miami site and some of our larger clinical pharmacology facilities, which offer additional speciality procedures, capabilities and complex study types.
Cloninger also said that nearly all 100 former PRACS staff employed at the facility will be joining CRI Phase I.
History
Fargo, North Dakota PRACS was formed after investment group Freeport Financial acquired the assets of Cetero Research earlier this year.
In 2011, the US Food and Drug Administration (FDA) raised significant concerns about bioequivalence and bioavailability data generated at Cetero’s clinical testing facility in Houston between 2005 and June 2010.
The ensuing scandal - which saw sponsors like Teva, Actavis and Ranbaxy ask the firm to repeat studies - eventually resulted in it filing for bankruptcy protection, selling its assets and changing its management. Cetero re-emerged as the PRACS Institute in June.
We asked if PRACS will sell any more former Cetero sites, Cloninger told us that: “There are currently no plans to sell or buy research operations.”
Phase I
CRI Phase I is a new organization that – according to a press statement – will use the Miami facility to conduct early and late-phase clinical research for biopharmaceutical and medical device companies.
The new firm will be led by former Cetero and PRACS investigator Hugo Romeu, while Will Garcia – who previously was previously PRACS’ senior clinical advisor will serve as VP of clinical affairs.